Requirements: English
Company: Barrington James
Region: Dijon , Bourgogne-Franche-Comt
This is a fantastic opportunity to be part of an innovative company that is committed to delivering high-quality medical devices to the market. As a Regulatory Affairs Officer , you will be responsible for ensuring compliance with medical device regulations and standards . You will work closely with the Quality Assurance & Regulatory Affairs Manager to: Lead change control projects related to evolving regulatory requirements. Ensure compliance with EU MDR, ISO 13485, FDA regulations , and other international requirements. Ensure timely renewal of market authorizations to support business continuity. Support customer complaint investigations and risk management processes . Oversee the release of finished products as part of the QARA teams business continuity plan. Work closely with internal teams , including R&D, Quality, and Supply Chain, to ensure regulatory requirements are met. Engage with regulatory authorities, notified bodies, suppliers, and external consultants to support compliance efforts. Lead and participate in regulatory project meetings and change control initiatives . Masters degree in Quality/Regulatory Engineering, Biomedical Science, or a related field . 3+ years of experience in Regulatory Affairs within the medical device industry . Strong knowledge of medical device regulations , including EU MDR, ISO 13485, FDA 21 CFR 820, and international standards . Understanding of risk management, CAPA processes, and quality systems . Work with cutting-edge medical technologies that make a real impact on patient lives.